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Harmful legal drugs: will anyone listen? Bitter Pills Inside the Hazardous World of Legal Drugs Stephen Fried. New York, Bantam Books. 1998. Pp 417. $24.95 ISBN 0-553-10383-0 tephen Fried’s Bitter Pills takes us on a long, dark walk into the world of harmful legal drugs and shows us the process by which they get approved. His experience provides a close-up look at the interactions between the US Food and Drug Administration (FDA) and the pharmaceutical industry. The author’s odyssey began in 1992 when his wife took a single pill of the antibiotic Floxin (ofloxacin) to treat a minor urinary tract infection and, in so doing, triggered severe and long-lasting central nervous system problems including visual distortions, insomnia, aphasia, and manic depression. To understand how such serious effects could result from an approved drug, Fried, a journalist, began to gather all the information available on Floxin, through literature
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searches and talking to scientists, FDA personnel, injured patients, and lawyers. The process triggered his interest into other drugs that had caused serious adverse reactions. Along the way, he discovered the enormous power of the pharmaceutical industry, something that I, as a former FDA pharmacology reviewer, witnessed. Fried found many reasons why approved drugs must either be removed from the market or have warnings added: most trial designs mandate the use of a relatively healthy group of patients, and there is a disinclination to allocate blame for adverse reactions on the drug being tested. Consequently, we seldom learn of potential serious sideeffects in a diverse population until after the drug is marketed; at that point, it is more difficult to ascertain cause and effect since only 1–10% of all drug adverse reactions are reported to the manufacturer or FDA. Since most drug research is being conducted by doctors on drug-company payrolls and with scientists hired as experts to argue the case before the FDA at advisory committee hearings, there is scant unbiased information. Even advisory committee members are often recipiTo spearhead its campaign for International Breast ents of grants from drug Cancer Awareness month (October), the UK Breast companies. Cancer Coalition (UKBCC) is launching a Further complicating 40-second film to raise awareness of the disease. doctors’ abilities to preIt Could be You highlights the disparity between the scribe the “best” drug for care and information that men and women with their patients, are the breast cancer receive in the UK because of where massive direct-to-conthey live, which hospital they attend, which sumer advertising camconsultant they see, and their own breast cancer paigns, the consumers awareness. The film, directed by Jon Blair, will be now being both doctors shown on various television networks and cinemas in and their patients. Fried the UK. Among the celebrities supporting the film reports that this advertisare ex-Spice Girl Geri Halliwell, Sheila Hancock, ing has been shown to M People’s Heather Small, and Sally Gunnell. provide much of the
Breast cancer awareness
THE LANCET • Vol 352 • October 3, 1998
information that doctors and consumers use, and the massive sums channelled to this purpose attest to its success. Fried makes the point that with such advertising, the line between over-the-counter and prescribed drugs has dimmed and that patients (and doctors?) begin to view all advertised drugs as innocuous. There is a need for this complex web of vested interests to be untangled. Fried’s pharmacologist friends have championed the idea of establishing a network of independent centres for drug research that would be a source of unbiased information. However, doctors also need to have as much savvy as any other group of consumers in terms of dealing with the marketing of legal drugs. They need to know how labels are written and what is left unsaid. One of the few things in Bitter Pills that I would disagree with is the use of the group, Motherisk, as an uncritical source of information on the teratogenicity of drugs. Motherisk uses human data from small groups of women referred to them for counselling after taking prescription drugs. Since Motherisk’s purpose is “protecting babies from unnecessary abortions”, there is an additional emotional element thrown into an already messy brew.Their comment that “Your baby has the same chance of being normal and going to college as the baby of a woman who was not treated” seems to extend beyond the available database since these children’s development is rarely systematically followed. The appendix has a section for consumers on how to read a drug “label” plus hints on how to avoid adverse drug reactions (but omits suggesting a waiting period to see what adverse events show up after approval). Fried has done a useful job in bringing together several examples where the drug approval system went awry along with some ideas as to how to prevent history from repeating itself. The question, as always, is: will anyone listen? Elizabeth K Barbehenn Public Citizen’s Health Research Group, 1600 20th Street NW, Washington, DC 20009-1001, USA
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searches and talking to scientists, FDA personnel, injured patients, and lawyers. The process triggered his interest into other drugs that had caused serious adverse reactions. Along the way, he discovered the enormous power of the pharmaceutical industry, something that I, as a former FDA pharmacology reviewer, witnessed. Fried found many reasons why approved drugs must either be removed from the market or have warnings added: most trial designs mandate the use of a relatively healthy group of patients, and there is a disinclination to allocate blame for adverse reactions on the drug being tested. Consequently, we seldom learn of potential serious sideeffects in a diverse population until after the drug is marketed; at that point, it is more difficult to ascertain cause and effect since only 1–10% of all drug adverse reactions are reported to the manufacturer or FDA. Since most drug research is being conducted by doctors on drug-company payrolls and with scientists hired as experts to argue the case before the FDA at advisory committee hearings, there is scant unbiased information. Even advisory committee members are often recipiTo spearhead its campaign for International Breast ents of grants from drug Cancer Awareness month (October), the UK Breast companies. Cancer Coalition (UKBCC) is launching a Further complicating 40-second film to raise awareness of the disease. doctors’ abilities to preIt Could be You highlights the disparity between the scribe the “best” drug for care and information that men and women with their patients, are the breast cancer receive in the UK because of where massive direct-to-conthey live, which hospital they attend, which sumer advertising camconsultant they see, and their own breast cancer paigns, the consumers awareness. The film, directed by Jon Blair, will be now being both doctors shown on various television networks and cinemas in and their patients. Fried the UK. Among the celebrities supporting the film reports that this advertisare ex-Spice Girl Geri Halliwell, Sheila Hancock, ing has been shown to M People’s Heather Small, and Sally Gunnell. provide much of the
Breast cancer awareness
THE LANCET • Vol 352 • October 3, 1998
information that doctors and consumers use, and the massive sums channelled to this purpose attest to its success. Fried makes the point that with such advertising, the line between over-the-counter and prescribed drugs has dimmed and that patients (and doctors?) begin to view all advertised drugs as innocuous. There is a need for this complex web of vested interests to be untangled. Fried’s pharmacologist friends have championed the idea of establishing a network of independent centres for drug research that would be a source of unbiased information. However, doctors also need to have as much savvy as any other group of consumers in terms of dealing with the marketing of legal drugs. They need to know how labels are written and what is left unsaid. One of the few things in Bitter Pills that I would disagree with is the use of the group, Motherisk, as an uncritical source of information on the teratogenicity of drugs. Motherisk uses human data from small groups of women referred to them for counselling after taking prescription drugs. Since Motherisk’s purpose is “protecting babies from unnecessary abortions”, there is an additional emotional element thrown into an already messy brew.Their comment that “Your baby has the same chance of being normal and going to college as the baby of a woman who was not treated” seems to extend beyond the available database since these children’s development is rarely systematically followed. The appendix has a section for consumers on how to read a drug “label” plus hints on how to avoid adverse drug reactions (but omits suggesting a waiting period to see what adverse events show up after approval). Fried has done a useful job in bringing together several examples where the drug approval system went awry along with some ideas as to how to prevent history from repeating itself. The question, as always, is: will anyone listen? Elizabeth K Barbehenn Public Citizen’s Health Research Group, 1600 20th Street NW, Washington, DC 20009-1001, USA
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